Aims. A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. Methods. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Results. Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. Conclusion. This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators’ meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631–637

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840

Aims. Diabetic foot care is a significant burden on the NHS in England. We have conducted a nationwide survey to determine the current participation of orthopaedic surgeons in diabetic foot care in England. Methods. A questionnaire was sent to all 136 NHS trusts audited in the 2018 National Diabetic Foot Audit (NDFA). The questionnaire asked about the structure of diabetic foot care services. Results. Overall, 123 trusts responded, of which 117 admitted patients with diabetic foot disease and 113 had an orthopaedic foot and ankle surgeon. A total of 90 trusts (77%) stated that the admission involved medicine, with 53 (45%) of these admissions being exclusively under medicine, and 37 (32%) as joint admissions. Of the joint admissions, 16 (14%) were combined with vascular and 12(10%) with orthopaedic surgery. Admission is solely under vascular surgery in 12 trusts (10%) and orthopaedic surgery in 7 (6%). Diabetic foot abscesses were drained by orthopaedic surgeons in 61 trusts (52%) and vascular surgeons in 47 (40%). Conclusion. Orthopaedic surgeons make a significant contribution to both acute and elective diabetic foot care currently in the UK. This contribution is likely to increase with the movement of vascular surgery to a hub and spoke model, and measures should be put in place to increase the team based approach to the diabetic foot, for example with the introduction of a best practice tariff. Cite this article: Bone Jt Open 2022;3(8):618–622

Aims. Management of intra-articular calcaneal fractures remains a debated topic in orthopaedics, with operative fixation often held in reserve due to concerns regarding perioperative morbidity and potential complications. The purpose of this study was to identify the characteristics of patients who developed surgical complications to inform the future stratification of patients best suited to operative treatment for intra-articular calcaneal fractures and those in whom surgery was highly likely to produce an equivocal functional outcome with potential post-operative complications. Methods. All patients who underwent open reduction and internal fixation of calcaneal fractures utilizing the Sinus Tarsi approach between March 2014 and July 2018 were identified using theatre records. Patient imaging was used to assess pre- and post-operative fracture geometry with Computed Tomography (CT) used for pre-operative planning. Each patient's clinical presentation was established through retrospective analysis of medical records. Patients provided verbal consent to participation and patient reported outcome measures were recorded using the Maryland Foot Score. Results. Fifty-eight intra-articular calcaneal fractures (fifty-three patients including five bilateral, mean age = 46.91 years) were included. Forty-nine patients were injured as a result of a fall from a height (92.4%). Mean time from presentation to surgery was 3.23 days (range 0–21). Mean Maryland Foot score was found to be 77.6 (+/− 16.22) in forty-five patients. Five patients (9.4%) had wound complications; two superficial (3.7%) and three deep (5.6%). Conclusion. Intra-articular fractures of the calcaneus should be considered for surgical intervention in order to improve long-term functional outcomes. The Sinus Tarsi approach provides the potential to decrease the operative complication rate whilst maintaining adequate fixation, however, the decision to surgically manage these fractures should be carefully balanced against the risk of post-operative complications. This increased risk of complication associated with smoking may tip the balance against benefit from surgical management

Introduction. Total ankle replacement as a valid treatment for end stage ankle arthritis, is gaining popularity and every year there is an increasing number of procedures. With revision rates as high as 21% at 5 years and 43% at 10 years there is a need for understanding and reporting the outcome of revision ankle replacement. Our aim was to study the patient reported outcomes following revision TAR with a minimum of 2 year follow up. Methods. All patients that underwent a revision total ankle replacement between 2012 and 2016 were included in the study. All patients received a post-operative questionnaire comprising of MOX-FQ score, EQ-5D (UK) and Foot and Ankle outcomes scores (FAOS) and patients satisfaction questionnaire with a minimum of 2 years follow up. Results. 33 patients had a revision total ankle replacement between 2012 and 2016. 2 patients were deceased therefore 31 patients were included in the study. 4 patients declined participation for completing questionnaires. We received 15/27 (55.5%) completed questionnaires. The mean MOX-FQ average domain score for pain was (50.6 ± 26.9), walking/standing (62.4 ± 36.5) and social function was (43.7± 31.0). The mean FAOS scores were (52.5 ± 30.6; pain), (54.5 ± 29.2; symptoms), (62.1 ± 30.5; ADL) and (35.5 ± 28.2; for quality of life). The mean overall health score today for EQ-5D was 73.9/100. 50% of patients were satisfied with the pain relief and return to sports and recreation obtained following the operation, 57% were satisfied with the improved in daily activities. 78.5% were overall satisfied with the results from surgery. Conclusion. Revision total ankle replacement gives overall satisfactory results demonstrated from patients reported outcomes at a minimum of 2 years following surgery

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The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture.

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To systematically review qualitative studies of patients with distal tibia or ankle fracture, and explore their experience of injury and recovery.

Aims. The objective of this double-blind randomised controlled trial was to assess whether ultrasound guidance improved the efficacy of corticosteroid injections for Morton’s neuroma (MN). . Patients and Methods. In all, 50 feet (40 patients) were recruited for this study but five feet were excluded due to the patients declining further participation. The mean age of the remaining 36 patients (45 feet) was 57.8 years (standard deviation (. sd. ) 12.9) with a female preponderance (33F:12M). All patients were followed-up for 12 months. Treatment was randomised to an ultrasound guided (Group A) or non-ultrasound guided (Group B) injection of 40 mg triamcinolone acetonide and 2 ml 1% lignocaine, following ultrasound confirmation of the diagnosis. . Results. The mean visual analogue score for pain improved significantly in both groups (Group A – from 64 mm, . sd. 25 mm to 29 mm, . sd. 27; Group B – from 69 mm, . sd. 23 mm to 37 mm, . sd. 25) with no statistical difference between them at all time-points. The failure rate within 12 months of treatment was 11/23 (48%) and 12/22 (55%) in Groups A and B, respectively (p = 0.458). The improvement in Manchester Oxford Foot Questionnaire Index and patient satisfaction favoured Group A in the short-term (three months) that almost reached statistical significance (p = 0.059 and 0.066 respectively). However, this difference was not observed beyond three months. . Conclusion. This study has shown that ultrasound guidance did not demonstrably improve the efficacy of corticosteroid injections in patients with MN. Take home message: In the presence of a clear diagnosis of MN, a trained clinician who understands the forefoot anatomy may perform an injection without ultrasound guidance with good and safe results. Cite this article: Bone Joint J 2016;98-B:498–503

Introduction:. PREMS and PROMS are part of the national initiative of the DoH. They measure quality from patient perspective and also help patient choice. We present our pioneering experience of PROMS 2.0 which is a semi automated web based system to collect and analyse outcome data in real time. Materials and methods:. Data was prospectively collected from January 2013 to June 2014. Outcome measures included EQ-5D VAS, EQ-5D Health Index, and MOxFQ, collected pre-operatively and post-operatively. Patient Personal Experience (PPE-15) was collected postoperatively. A semi-automated e mail based system – Amplitude – was used. Results:. 345 patients consented to participate.147 patients (42.6%) and 168 pathways (47%) signed up for PROMs 2.0 programme. 40 (27%) did not complete either pre-op or post op questionnaire after signing up. 30 patients (20.4%) completed pre-op and at least one post op score. 99 patients (58.9%) completed PPE questionnaire. 83% of respondents had improved or unchanged EQ-5D VAS score, and EQ-5D Health Index. MOxFQ scores showed improvement in over 80% of responses. 88% responded favourably (YES) to PPE 15 questionnaire. Conclusion:. Our data shows an improvement in PROMS and a favourable PREMS in excess of 80% of our elective foot & ankle patients following surgery. Patient response was higher for PPE questionnaire compared to other PROMs outcomes. Methods to increase patient enrolment and to encourage higher participation are required. We feel patient education and simplification of PROMS 2.0 are the key

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The ideal management of acute syndesmotic injuries in elite athletes is controversial. Among several treatment methods used to stabilize the syndesmosis and facilitate healing of the ligaments, the use of suture tape (InternalBrace) has previously been described. The purpose of this study was to analyze the functional outcome, including American Orthopaedic Foot & Ankle Society (AOFAS) scores, knee-to-wall measurements, and the time to return to play in days, of unstable syndesmotic injuries treated with the use of the InternalBrace in elite athletes.

We describe five adolescent patients aged between 13 and 16 years with bipartite ossification of the posteromedial aspect of the talus. All presented without a history of trauma. All the ankles had a similar radiological appearance. Clinically, some restriction of movement was noted in three ankles and two subtalar joints, In addition, pain was noted over the posteromedial aspect of the ankle in three patients. In each patient the bipartite fragment was excised through a posteromedial approach to the ankle. Complete resolution was achieved at six months in three patients, with the remaining two describing exercise-induced symptoms. In one of these this precluded participation in sport. Despite numerous anatomical variations within the tarsus, a case series of a bipartite talus has not previously been reported. This anatomical variation should be recognised to avoid misinterpretation as post-traumatic or other pathological processes. In the presence of recalcitrant symptoms excision is an option, but this is not universally successful in abolishing symptoms

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The aim of this study was to investigate whether on-demand removal (ODR) is noninferior to routine removal (RR) of syndesmotic screws regarding functional outcome.

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A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients’ quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures.

The patient-reported Manchester-Oxford Foot Questionnaire (MOXFQ), with 3 dimensions (Walking/standing(W/S), Pain, Social interaction(SI)) has previously been validated in patients undergoing hallux valgus surgery. A preliminary cross-sectional evaluation of its measurement properties relating to surgery on different regions of the foot and ankle is presented here. Within 4 weeks prior to foot or ankle surgery, 671of 764 consecutive eligible patients (87.8% response rate) were assessed with the: (i) MOXFQ questionnaire, (ii) SF-36 general health survey (iii) American Orthopaedic Foot & Ankle Society (AOFAS) scales. Sample characteristics: mean age 53 years 427 (63.6%) female. Patients were booked for (main) surgery on Hallux (210, 31.3%), Lesser Toes (119, 17.7%), Mid foot (22, 3.3%), Ankle/Hind foot (311, 46.3%) and whole foot/multiple regions (9, 1.3%). MOXFQ item response rates were high (<2% missing on any one item) with responses generally well distributed across response categories. Item-total correlations within each dimension were generally above recommended levels. Internal consistency, as assessed by Cronbach's alpha, were 0.93, 0.84 and 0.71 for the W/S, Pain and SI dimensions, respectively. Within Hallux, Lesser toes and Ankle/hind foot surgical subgroups (low numbers precluded mid foot and whole/multiple region analyses), alphas for these subscales were similar. Convergent validity of MOXFQ was demonstrated by correlations between the 3 dimensions (W/S, Pain, SI) with similar dimensions of the SF-36 and relevant AOFAS scales. A priori hypotheses were generally supported. The MOXFQ demonstrates good baseline measurement properties in patients undergoing a range of foot and ankle surgery, suggesting its suitability as an outcome measure for clinical trials of foot and ankle surgery in general. The SI dimension, concerned with cosmesis and social participation has somewhat weaker properties but remains useful. Evidence for the MOXFQ's responsiveness across the range of foot and ankle surgery is yet to be assessed

Injuries to the foot in athletes are often subtle and can lead to a substantial loss of function if not diagnosed and treated appropriately. For these injuries in general, even after a diagnosis is made, treatment options are controversial and become even more so in high level athletes where limiting the time away from training and competition is a significant consideration.

In this review, we cover some of the common and important sporting injuries affecting the foot including updates on their management and outcomes.

Cite this article: Bone Joint J 2016;98-B:1299–1311.

Van Nes rotationplasty may be used for patients with congenital proximal focal femoral deficiency (PFFD). The lower limb is rotated to use the ankle and foot as a functional knee joint within a prosthesis. A small series of cases was investigated to determine the long-term outcome. At a mean of 21.5 years (11 to 45) after their rotationplasty, a total of 12 prosthetic patients completed the Short-Form (SF)-36, Faces Pain Scale-Revised, Harris hip score, Oswestry back pain score and Prosthetic Evaluation Questionnaires, as did 12 age- and gender-matched normal control participants. A physical examination and gait analysis, computerised dynamic posturography (CDP), and timed ‘Up & Go’ testing was also completed. Wilcoxon Signed rank test was used to compare each PFFD patient with a matched control participant with false discovery rate of 5%.

There were no differences between the groups in overall health and well-being on the SF-36. Significant differences were seen in gait parameters in the PFFD group. Using CDP, the PFFD group had reduced symmetry in stance, and reduced end point and maximum excursions.

Patients who had undergone Van Nes rotationplasty had a high level of function and quality of life at long-term follow-up, but presented with significant differences in gait and posture compared with the control group.

Cite this article: Bone Joint J 2013;95-B:192–8.

We investigated 60 patients (89 feet) with a mean age of 64 years (61 to 67) treated for congenital clubfoot deformity, using standardised weight-bearing radiographs of both feet and ankles together with a functional evaluation. Talocalcaneal and talonavicular relationships were measured and the degree of osteo-arthritic change in the ankle and talonavicular joints was assessed. The functional results were evaluated using a modified Laaveg-Ponseti score. The talocalcaneal (TC) angles in the clubfeet were significantly lower in both anteroposterior (AP) and lateral projections than in the unaffected feet (p < 0.001 for both views). There was significant medial subluxation of the navicular in the clubfeet compared with the unaffected feet (p < 0.001). Severe osteoarthritis in the ankle joint was seen in seven feet (8%) and in the talonavicular joint in 11 feet (12%). The functional result was excellent or good (≥ 80 points) in 29 patients (48%), and fair or poor (< 80 points) in 31 patients (52%). Patients who had undergone few (0 to 1) surgical procedures had better functional outcomes than those who had undergone two or more procedures (p < 0.001). There was a significant correlation between the functional result and the degree of medial subluxation of the navicular (p < 0.001, r² = 0.164), the talocalcaneal angle on AP projection (p < 0.02, r2 = 0.025) and extent of osteoarthritis in the ankle joint (p < 0.001).

We conclude that poor functional outcome in patients with congenital clubfoot occurs more frequently in those with medial displacement of the navicular, osteoarthritis of the talonavicular and ankle joints, and a low talocalcaneal angle on the AP projection, and in patients who have undergone two or more surgical procedures. However, the ankle joint in these patients appeared relatively resistant to the development of osteoarthritis.

The outcome in 83 patients with congenital clubfoot was evaluated at a mean age of 64 years using three validated questionnaires assessing both quality of life (short-form (SF)-36 and EQ-5D) and foot and ankle function (American Academy of Orthopaedic Surgeons (AAOS) Foot and Ankle questionnaire). In SF-36, male patients scored significantly better than male norms in seven of the eight domains, whereas female patients scored significantly worse than female norms in two of the eight. Male patients scored better than male norms in both the EQ-5D index (p = 0.027) and visual analogue scale (VAS) (p = 0.013), whereas female patients scored worse than female norms in the VAS (p < 0.001). Both male and female patients had a significantly worse outcome on the AAOS Core Scale than did norms. There was a significant correlation for both genders between the SF-36 Physical Component Summary Score and the AAOS Core Scale.

The influence on activities of daily life was limited to foot and ankle problems in all patients, and in females there was an adverse effect in physical aspects of quality of life.

We developed the Oxford ankle foot questionnaire to assess the disability associated with foot and ankle problems in children aged from five to 16 years. A survey of 158 children and their parents was carried out to determine the content, scaling, reliability and validity of the instrument. Scores from the questionnaire can be calculated to measure the effect of foot or ankle problems on three domains of children’s lives: physical, school and play, and emotional. Scores for each domain were shown to be internally consistent, stable, and to vary little whether reported by child or parent. Satisfactory face, content and construct validity were demonstrated. The questionnaire is appropriate for children with a range of conditions and can provide clinically useful information to supplement other assessment methods. We are currently carrying out further work to assess the responsiveness of questionnaire scores to change over time and with treatment.